There are about 13332 clinical studies being (or have been) conducted in Netherlands. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Our primary objective is to design a cohort to determine the treatment outcome of different surgical interventions of the degenerative lumbar spine highlighting the expediency and value of the current surgical treatment program.
The first primary objective is to assess the effect of three intra-arterial administrations of autologous mesoangioblasts (MABs) with respect to improving muscle strength and reduce fatigue of the treated biceps brachii (BB) compared to the untreated BB. The second primary objective is safety of three intra-arterial administrations of autologous MABs, which the investigators will assess by monitoring (serious) adverse events ((S)AEs), blood flow in left arm pre- and post-intervention, and neurological vital signs during 8h post-intervention observation in the hospital. Secondary objectives are to assess changes in muscle mass of the treated and untreated BB muscle, and microscopic changes and m.3243A>G mutation load at tissue level in treated biceps brachii (BB) muscle at baseline and after treatment. Up to 20 adult m.3243A>G patients will undergo a ~30mg m. biceps brachii muscle biopsy at visit 1. The first six eligible patients will enroll the clinical study based on their m.3243A>G mutation load in skeletal muscle (50-90%) and mesoangioblasts (<10%), and on a decreased BB muscle strength and increased fatigue. These 6 selected patients will visit the Maastricht University Medical Center for 8 additional times. From each patient, during visit 2 till 9: - BB muscle biopsies of the left arm will be collected (1x ~130 mg at visit 2 and 1x ~30mg at visit 9) - MRI of the BB muscles in both arms will be performed (visit 2 and 9). - Autologous MABs will be injected into the left arm via axillary artery delivery. Angiography will be performed before and after infusion to assess vascular obstructions, and the participant will be monitored in the hospital for 8 hours (visit 4,6,8). - Tc99m macroaggregated albumin (MAA) is infused to quantify blood flow to the BB muscle (visit 4). - A bout of maximal eccentric exercise of BB muscles on both sides will be executed at visit 3, 5 and 7. - BB muscle strength will be assessed using a Biodex dynamometer (visit 3-9) - venous blood samples will be taken for assessing muscle damage and inflammation markers (visit 3-9), kidney functioning, coagulation and viral screening (visit 1 and 2).
Post-surgical (bacterial) infections are the most frequent post-surgical complications, including deep or superficial wound infections, urinary tract infections, pneumonia, and even sepsis. Approximately 6.5-25% of all surgical patients will develop any type of bacterial infection. To personalize surgical infection management, (Artificial Intelligence) models are in the making to predict which patients are at high or low risk of developing a post-surgical infection. In order to benchmark these prediction models to the predictive capabilities of surgeons, the investigators aim to investigate the performance of surgeons in predicting the risk of a patient developing (any type) of post-surgical infection within 30 days.
The goal of this monocenter randomized pilot study is to investigate the usability of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures. The main question it aims to answer is: - What is the usability score of the ADEPTH sensor for bore depth measurements during plate osteosynthesis procedures? Participants will receive either bore depth measurements with the ADEPTH sensor or with the manual depth gauge.
The investigators designed an observational multicenter explorative in vivo study to investigate the changes in ceftriaxone pharmacokinetics in blood and ascites. The investigators will include a total of 20 patients with liver cirrhosis admitted to the ward of participating hospitals. Patients are eligible when receiving ceftriaxone and concomitantly receive paracentesis. The investigators will collect all available waste blood samples of each participant, starting from study entry up until 48 hours after the last dosing interval of ceftriaxone. The investigators will collect all available waste ascites samples of each participant up until 48 hours after the last dosing interval of ceftriaxone. Duration of the trial: The study duration is variable and depends on the duration of ceftriaxone treatment and duration of hospital admission, which both are determined by the treating physician and is not influenced by study participation. Patients will be eligible for study inclusion when patients received (a single dose of) ceftriaxone treatment and undergo paracentesis during ceftriaxone treatment. The study will end 48 hours after the last dosing interval of ceftriaxone or until hospital discharge, whichever comes first. Study timeline: The investigators expect to enrol 1-2 participants every month. The total enrolment time will thus be approximately 12 months.
The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life. The trial will last for up to 40 weeks. There will be up to 15 visits, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants are off the drug for safety follow-up.
The goal of this clinical trial is to evaluate the clinical use of [68Ga]Ga-FAPI-46 PET (positron emission tomography)/CT (computed tomography) imaging in patients with pancreatic or bile duct cancer. The study consists of three parts and patients can only participate in one part of the study. The main questions the study aims to answer are: - In part A: What is the best timing and scanprotocol of a [68Ga]Ga-FAPI-46 PET/CT scan? - In part B: Are the results of the simplified scan protocol repeatable? - In part C: What is the accuracy of [68Ga]Ga-FAPI-46 PET/CT to detect pancreatic cancer and is it able to detect the effect of chemotherapy on pancreatic cancer lesions? Participants in this study will be asked to undergo the following: - In part A: participants will undergo 1 [68Ga]Ga-FAPI-46 PET/CT scan and will have 2 venous canullas and 1 arterial cannula placed. - In part B: participants will undergo 2 [68Ga]Ga-FAPI-46 PET/CT scans and will have a venous cannula placed for each scan. - In part C: participants will undergo 2 [68Ga]Ga-FAPI-46 PET/CT scans and will have a venous cannula placed for each scan.
This observational clinical, single center trial is designed to evaluate the implementation of an already validated smart monitoring device, the Philips Healthdot, on one surgical ward at the Catharina hospital in Eindhoven, The Netherlands. This study is performed during 6 months in which all patients admitted to one surgical ward will be enrolled. Implementation is established by a step-by-step approach in which the current manually performed spot check monitoring (blood pressure, oxygen saturation, respiratory rate, heart rate, temperature and pain score), with the early warning score (EWS), is continued besides smart monitoring with the Healthdot (respiratory rate, heart rate and physical activity) during the first three months (phase 1). This phase aims at optimizing the infrastructure, education of hospital staff and practice with application/ activation and interpretation of the device. Upward of 4 months, Healthdot monitoring will be the primary monitoring method and spot check monitoring is only performed additionally in case of doubt about clinical condition or requirement of additional vital parameters. Evaluation of the implementation will be performed with a focus group and various questionnaire regarding fidelity, acceptability, adoption, feasibility, appropriateness and costs. Thereby additional analysis regarding monitoring algorithms will be performed.
The goal of this clinical trial is to test a new PET tracer in patients with HER2-positive breast or gastric cancer. This tracer is made of radioactively labeled trastuzumab, and can show where HER2 is present in the body using a PET-scan. For this research, the investigators make PET-scans in people with HER2-positive, metastasized breast- or gastric cancer. The investigators will investigate if the new HER2-tracer correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain HER2-directed therapies. Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 60 minutes. The PET-scans are on separate days within a week after injection of the tracer (e.g. 1 day, 2 days and 4 days after injection). Furthermore, the investigators will take 7 blood samples (5 mL each). Participants are not required to stay at the hospital. The first 3 participants will undergo an extra PET-scan 1 - 2 hours after injection. The amount of radioactivity injected will be 37 MBq (± 10%).
Study design: A randomized controlled trial will be used, where patients will be randomized (1:1) to either the control group receiving usual care or the intervention group in which patients will receive usual care in combination with the TIMELY intervention for a duration of 6 months. Study sample: Female and male patients aged 18 years or over, with documented stable CAD and referred for cardiac rehabilitation (at > 2 weeks but <10 weeks after PCI or >4 weeks but <12 weeks after CABG or MI: STEM or non-STEMI), and/or having documented CAD by coronary angiography (stenosis in a major coronary artery >50%). Intervention: Patients randomized to the intervention group will receive the TIMELY app on their phones or tablets for 6 months. Patients will also receive a wearable activity tracker that collects activity levels, heart rate and sleep characteristics. Based on patient's activity levels, self-reported momentary mental states, health-related behaviors and environmental and clinical background factors, the app will enable patient-tailored recommendations relevant to improving lifestyle behaviors during daily life. In addition, patients will receive a blood pressure monitor that measures hemodynamic parameters through pulse wave analysis and an easy-to-use ECG device which will be used to assess changes in heart rate and other cardiovascular measures at rest and with exercise. Main study parameters/endpoints: The primary biomedical outcome is a change in the CoroPredict biomarker risk score from baseline (pre-randomization) to completion of the active intervention phase (6 months). The CoroPredict score is an indicator of the 10-year risk of mortality. The primary behavioral outcome is the change from baseline to 6 months in patients' functional status of fitness level (measured using the 6-minute walk test). The study further aims to improve secondary outcome measures: physical activity levels during daily life and cardiovascular responses to exercise, dietary habits, smoking behavior, medication adherence and perceived levels of psychological stress.